QT Interval in Patients With Pacemaker Dependency

NCT01694550 | Completed DMC

• 1 other identifier: OVGU-Kar-011
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to examine a correction term for an adapted QT interval during ventricular pacing (right, left and biventricular pacing) to obtain valid formulae correcting for the QT intervals in various pacing conditions.

Conditions

High Degree AV-block; Left Bundle Branch Block

Keywords

pacemaker; ICD / CRTD; corrected QT-interval

Outcome Measures

Primary Outcomes (1)

• Corrected QT Interval in Patients With Pacemaker Dependency

  baseline

Study Arms (1)

Pacemaker mode programming

High grade AV-block

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will enroll 180 patients after an implantation of cardioverter/defibrillator or pacemaker based on a standard guideline indication. The point of enrolment for all patients is the time at which the patient signs and dates the ICF during the hospital stay in the context of implantation.

You may qualify if:

• caucasian race
• implanted cardioverter/defibrillator or pacemaker
• negative pregnancy test for women of child bearing potential
• stable function of the implanted device
• stable medical therapy relating to the underlying disease
• stable medical therapy of antiarrhythmic drugs and other QT-time changing drugs
• no instability of rhythm
• x-ray of thorax during device implantation in two levels (ap and ll axis)
• written informed consent

You may not qualify if:

• coronary heart disease and angina pectoris symptoms
• patient with acute myocardial infarction or CABG while the last 4 weeks
• patient with tachycardia and a rest frequency \>80 bpm
• patient with severe pulmonary disease
• patient with anaemia
• patient with acute infections
• patient with severe kidney or liver disease

Sponsors & Collaborators

• University of Magdeburg: lead

Study Sites (1)

Magdeburg University, Internal Medicine/Cardiology, Angiology and Pneumologie

Magdeburg, 39120, Germany

Location

Biospecimen

Retention: NONE RETAINED

No biospecimen are necessary for the study and this issue is irrelevant.

MeSH Terms

Conditions

Bundle-Branch Block

Condition Hierarchy (Ancestors)

Heart Block; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Samir Said, Dr.

  Magdeburg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: September 24, 2012
• First Posted: September 27, 2012
• Study Start: March 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2016
• Last Updated: October 28, 2016

Record last verified: 2016-10

Locations

DE (1)